Product code JBP
- Device name
- Activated Whole Blood Clotting Time
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7140
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | Sienco, Inc. | 2023-01-04 |
| K062604 | RAPIDTEG TEG-ACT TEST | Haemoscope Corp. | 2007-01-31 |
| K032952 | AIACT KIT | Sienco, Inc. | 2003-12-12 |
| K023582 | I-STAT KAOLIN ACT TEST | I-Stat Corporation | 2003-09-08 |
| K020914 | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 | Helena Laboratories | 2002-05-23 |
| K013078 | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 | Helena Laboratories | 2002-01-10 |
| K002528 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION | Sienco, Inc. | 2000-08-31 |
| K994194 | (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT | Cardiovascular Diagnostics, Inc. | 2000-03-28 |
| K992571 | I-STAT SYSTEM | I-Stat Corp. | 2000-02-10 |
| K992851 | ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM | Roche Diagnostics Corp. | 2000-01-14 |
| K984141 | GBACT + KIT | Sienco, Inc. | 1999-05-28 |
| K983649 | MAX-ACT | Array Medical, Inc. | 1998-12-11 |
| K971935 | B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) | B & D Corp. | 1997-10-01 |
| K964609 | ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE | Array Medical, Inc. | 1997-03-06 |
| K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | International Technidyne Corp. | 1996-08-12 |
| K941007 | CATALOG NO. J-ACT+ & QC-ACT+ | International Technidyne Corp. | 1994-06-30 |
| K923594 | CLOTTRAC COAGULATION CONTROL | Medtronic Hemotec, Inc. | 1992-09-21 |
| K913861 | HEMOCHRON(R) KACT | International Technidyne Corp. | 1991-10-18 |
| K902081 | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL | Hemotec, Inc. | 1990-07-03 |
| K854686 | TE-25 COAGURO METER | Future Impex Corp. | 1986-06-04 |
| K860122 | HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME | Medical Device Consultants, Inc. | 1986-04-04 |
| K843459 | HEMOTEC ACT I SYSTEM | Hemotec, Inc. | 1984-12-12 |
| K832189 | HEMOCHRON THROMBOCHRONOMETER | International Technidyne Corp. | 1983-10-14 |
| K790346 | ACTIVATOR | Tri-Med, Inc. | 1979-03-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20763000558332 | HR HTC | MEDTRONIC, INC. | 2026-02-23 |
| 00763000558338 | HR HTC | MEDTRONIC, INC. | 2026-02-23 |
| 20763000558219 | CLOTtrac™ | MEDTRONIC, INC. | 2026-02-22 |
| 20763000558202 | CLOTtrac™ | MEDTRONIC, INC. | 2026-02-22 |
| 20763000558196 | CLOTtrac™ | MEDTRONIC, INC. | 2026-02-22 |
| 00763000558239 | CLOTtrac™ | MEDTRONIC, INC. | 2026-02-22 |
| 00763000558222 | CLOTtrac™ | MEDTRONIC, INC. | 2026-02-22 |
| 00763000558215 | CLOTtrac™ | MEDTRONIC, INC. | 2026-02-22 |
| 00763000558208 | CLOTtrac™ | MEDTRONIC, INC. | 2026-02-22 |
| 00763000558192 | CLOTtrac™ | MEDTRONIC, INC. | 2026-02-22 |
| 20763000433844 | HR-ACT | MEDTRONIC, INC. | 2023-04-08 |
| 20763000433813 | LR-ACT | MEDTRONIC, INC. | 2023-04-08 |
| 20763000441450 | NA | MEDTRONIC, INC. | 2023-04-07 |
| 10711234103401 | GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+) | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2022-01-21 |
| 10711234103418 | GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR) | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2022-01-21 |
| 20643169730155 | N/A | MEDTRONIC, INC. | 2021-11-12 |
| B55880004411 | Sonoclot® aiACT Kit | SIENCO, INC. | 2021-07-19 |
| B55880004421 | Sonoclot® aiACT Kit | SIENCO, INC. | 2021-07-19 |
| B55880004111 | Sonoclot® gbACT+ Kit | SIENCO, INC. | 2021-05-26 |
| B55880004121 | Sonoclot® gbACT+ Kit | SIENCO, INC. | 2021-05-26 |
| 10711234103067 | Hemochron Whole Blood Microcoagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2016-09-22 |
| M525CACT0 | C-ACT Tubes | HELENA LABORATORIES CORPORATION | 2016-08-22 |
| M525GACT0 | G-ACT Tubes | HELENA LABORATORIES CORPORATION | 2016-08-22 |
| M525MAXACT0 | Actalyke MAX-ACT Tubes | HELENA LABORATORIES CORPORATION | 2016-08-22 |
| M525KACT0 | K-ACT Tubes | HELENA LABORATORIES CORPORATION | 2016-08-22 |
| 10885074184880 | CLOTtrac® | MEDTRONIC, INC. | 2016-06-18 |
| 10885074184873 | CLOTtrac® | MEDTRONIC, INC. | 2016-06-18 |
| 10885074184910 | CLOTtrac® | MEDTRONIC, INC. | 2016-06-18 |
| 10885074184927 | CLOTtrac® | MEDTRONIC, INC. | 2016-06-18 |
| 10885074117314 | HR HTC | MEDTRONIC, INC. | 2016-06-13 |